JP2016525572A5 - - Google Patents

Claims (27)

(I) a film-forming polymer, wherein the film-forming polymer is polyvinyl acetate and the concentration of polyvinyl acetate in the mouth-dispersible film is 30-95% by weight; (ii) a disintegrant and (iii) polyvinyl It encompasses alcohol (PVA) or hydroxypropylmethyl cellulose (HPMC), orodispersible film. The mouth dispersible film according to claim 1, wherein the disintegrant is (i) a cellulose derivative, (ii) a cellulose ether, (iii) carboxymethylcellulose or a salt thereof, or (iv) sodium carboxymethylcellulose. The intraoral dispersible film according to claim 1 or 2 , further comprising one or more dispersants . One or more dispersants are (i) sodium lauryl sulfate, (ii) povidone, (iii) macrogolcetostearyl ether, and (iv) one or two of sorbic acid and sodium hydroxide. including more, orodispersible film according to claim 3. The intra-oral dispersible film according to any one of claims 1 and 3 , further comprising a plasticizer. Plasticizer, (i) citrate derivatives, (ii) triethyl citrate, (iii) glycerol, (iv) a polyethylene glycol or (v) profiles propylene glycol, orodispersible film according to claim 5. The intra-oral dispersible film according to any one of claims 1 to 6 , wherein the concentration of at least one of polyvinyl alcohol and hydroxypropyl methylcellulose in the intra- oral dispersible film is 5 to 17.5% by weight. (I) one or more sweeteners, (ii) one or more colorants, (iii) one or more flavorings, and (iv) one or more salivas. The intra-oral dispersible film according to any one of claims 1 to 7 , further comprising one or more of secretagogues. Concentration of Po polyvinyl alcohol or hydroxypropylmethyl cellulose in orodispersible film is 1 to 21 wt%; and,
Disintegrant, carboxymethyl a cellulose sodium, wherein a 1 to 22 wt% concentration of sodium carboxymethyl cellulose in orodispersible film;
The intraoral dispersible film according to any one of claims 1 to 8 , wherein the total weight percentage of all components of the intraoral dispersible film does not exceed 100%. The intraoral dispersible film according to claim 9 , wherein the concentration of polyvinyl acetate in the intraoral dispersible film is 30 to 60% by weight. The concentration of polyvinyl alcohol or hydroxypropyl methyl cellulose in orodispersible film is from 5 to 17.5 wt%, orodispersible film of claim 10. The intra-oral dispersible film according to claim 11 , further comprising a plasticizer. The intra-oral dispersible film according to any one of claims 1 to 12, further comprising an active agent which is a pharmaceutical, a nutraceutical agent, a supplement or a cosmetic agent. 14. A method for delivering an orally dispersible film according to any one of claims 1 to 13, comprising placing the film in the oral cavity for a period of time sufficient to disintegrate. The dispersible film in any one of claims 1 to 13, wherein the disintegration time of the dispersible film in contact with the oral mucosa is less than or equal to 90 seconds. The mouth-dispersible film according to any one of claims 1 to 15, wherein the disintegration time of the mouth-dispersible film in contact with the oral mucosa is less than or equal to 45 seconds. The intraoral dispersible film according to any one of claims 1 to 13, 15 and 16, wherein the concentration of polyvinyl acetate in the intraoral dispersible film is 30 to 60% by weight. The mouth dispersible film according to any one of claims 1 to 13, 15 to 17, wherein a concentration of the disintegrant in the mouth dispersible film is 1 to 22% by weight. The mouth-dispersible film according to any one of claims 1 to 13, 15 to 19, wherein a concentration of the disintegrant in the mouth-dispersible film is 5 to 17.5% by weight. The intraoral dispersible film according to any one of claims 1 to 13, 15 to 19, wherein the concentration of at least one of polyvinyl alcohol or hydroxypropylmethylcellulose in the intraoral dispersible film is 1 to 21% by weight. The mouth-dispersible film according to any one of claims 1 to 13, 15 to 19, wherein the concentration of at least one of polyvinyl alcohol or hydroxypropylmethylcellulose in the mouth-dispersible film is 5 to 17.5% by weight. The intraoral dispersible film according to any one of claims 3 to 13, 15 to 21, wherein the concentration of the one or more dispersants in the intraoral dispersible film is 0.001 to 10% by weight. The intraoral dispersible film according to any one of claims 5 to 13 and 15 to 22, wherein the concentration of the plasticizer in the intraoral dispersible film is 1 to 20% by weight. The intraoral dispersible film according to any one of claims 1 to 13, 15 to 23, wherein the polyvinyl alcohol or hydroxypropylmethylcellulose is polyvinyl alcohol. The intraoral dispersible film according to any one of claims 1 to 13, 15 to 23, wherein the polyvinyl alcohol or hydroxypropylmethylcellulose is hydroxypropylmethylcellulose. The weight ratio of (1) the concentration of polyvinyl acetate in the mouth-dispersible film to (2) the concentration of polyvinyl alcohol or hydroxypropyl methylcellulose in the mouth-dispersible film is 20: 1 to 1: 1. The intraoral dispersible film according to any one of 15 to 25. The intra-oral dispersible film according to claim 9, further comprising an active agent which is a pharmaceutical, a nutraceutical agent, a supplement or a cosmetic agent.